FDA.reportPublic FDA data

DIGITAL DIAGNOSTICS SYSTEM

Primary DI
15420045517585
Brand
DIGITAL DIAGNOSTICS SYSTEM
Company
Hologic, Inc.
Model
ASSEMBLY, REVIEW STATION COMPUTER
Catalog number
ASY-17964
Device description
Computer to operate the Genius™ Review Station.
Published
2025-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYVDigital cervical cytology slide imaging system with artificial intelligence algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYVDigital Cervical Cytology Slide Imaging System With Artificial Intelligence AlgorithmPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210035000“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”Hologic, Inc.2024-01-31QYV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045517585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551758515420045517585

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045517097DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2025-07-17
15420045513877DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513884DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513907DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513914DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513921DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513976DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045514201DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07